跳至主要内容
临床试验/NCT05586867
NCT05586867招募中不适用

Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

Ramsay Générale de Santé1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).

研究概览

简要总结

From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure.

The study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients.

The main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult dialysis patient
  • Patient able to understand the information necessary for the study and having signed his written consent to participate
  • Affiliated patient or beneficiary of a social security scheme.

排除标准

  • Medically unstable or frail patient
  • Patient with hemoglobin less than 7g/dl
  • Patient with HIV+ or AIDS, patient with replicating hepatitis B or C
  • Patient participating in another clinical study requiring an additional blood sample
  • Patient benefiting from legal protection measures (guardianship, guardianship, etc.) adult under guardianship, guardianship or other legal protection, deprived of freedom by judicial or administrative decision
  • Pregnant, breastfeeding or parturient woman

结局指标

主要结局

concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).

时间窗: 5 years

These will be dosed twice over a year of dialysis and for 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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